Positioning system for manipulating a channel within a medical device

ABSTRACT

Embodiments of the invention include a medical device for accessing a patient&#39;s body portion and used for diagnosis and treatment of medical conditions. Embodiments of the invention may include a particular endoscopic positioning mechanism for placing an endoscope and an additional treatment device within desired body portions in order to assist in diagnosis and treatment of anatomical diseases and disorders. In particular, a medical device according to an embodiment of the invention includes a positioning mechanism configured for movement through at least two degrees of freedom.

FIELD OF THE INVENTION

The invention relates to an endoscope system for accessing a patient'sbody portion and used for diagnosis and treatment of medical conditions.For example, embodiments of the invention may include a particularendoscopic positioning mechanism for placing an endoscope and anadditional treatment device within desired body portions in order toassist in diagnosis and treatment of anatomical diseases and disorders.

BACKGROUND OF THE INVENTION

Endoscopes for medical use have been adopted for various diagnostic andmedical treatment procedures. Endoscopes have been used for thediagnosis and treatment of a wide range of diseases and disorders thatoften require a physician to access the tortuous and relatively smallcross-sectional areas of a patient's internal anatomical body lumens. Apatient's pancreaticobiliary system (including the anatomical regions ofthe gall bladder, pancreas, and the biliary tree), for example, isaccessed for diagnosis, and/or treatment of disorders of certainportions of the digestive system.

During treatment of the digestive system, endoscopes are often used toaccess and visualize a patient's pancreaticobiliary system. Once theendoscope is positioned in the desired body portion, a treatmentinstrument can be advanced through the working channel of the endoscopeto the desired body portion. The endoscope and treatment instrument maythen be manipulated as desired for visualization and treatmentrespectively.

Endoscopic retrograde cholangiopancreatography (ERCP) is one example ofa medical procedure that uses an endoscope. ERCP enables the physicianto diagnose problems in the liver, gallbladder, bile ducts, andpancreas. The liver is a large organ that, among other things, makes aliquid called bile that helps with digestion. The gallbladder is asmall, pear-shaped organ that stores bile until it is needed fordigestion. The bile ducts are tubes that carry bile from the liver tothe gallbladder and small intestine. These ducts are sometimes calledthe biliary tree. The pancreas is a large gland that produces chemicalsthat help with digestion and hormones such as insulin.

The biliary system delivers bile produced by the liver to the duodenumwhere the bile assists other gastric fluids in digesting food. Thebiliary system includes the liver, as well as a plurality of bodilychannels and organs that are disposed between the liver and theduodenum. Within the liver lobules, there are many fine “bile canals”that receive secretions from the hepatic cells. The canals ofneighboring lobules unite to form larger ducts, and these converge tobecome the “hepatic ducts.” They merge, in turn, to form the “commonhepatic duct.” The “common bile duct” is formed by the union of thecommon hepatic and the cystic ducts. It leads to the duodenum, where itsexit is guarded by a sphincter muscle. This sphincter normally remainscontracted until the bile is needed, so that bile collects in the commonbile duct and backs up to the cystic duct. When this happens, the bileflows into the gallbladder and is stored there.

ERCP is used primarily to diagnose and treat conditions of the bileducts, including gallstones, inflammatory strictures (scars), leaks(from trauma and surgery), and cancer. ERCP combines the use of x-raysand an endoscope. Through the endoscope, the physician can see theinside of the stomach and duodenum, and inject dyes into the ducts inthe biliary tree and pancreas so they can be seen on x-rays.

An ERCP is performed primarily to identify and/or correct a problem inthe bile ducts or pancreas. For example, if a gallstone is found duringthe exam, it can often be removed by means of a treatment instrument,eliminating the need for major surgery. If a blockage in the bile ductcauses yellow jaundice or pain, it can be relieved through the use of atreatment instrument inserted through the endoscope.

Since endoscopes are often used to access the tortuous and relativelysmall cross-sectional areas of a patient's internal anatomical bodylumens, repeated manipulation and positioning of an endoscope during amedical procedure can cause problematic side-effects. For example,repeated manipulation and positioning of the endoscope can causeunnecessary trauma to a patient's internal tissues. Improper placementand repeated attempts to access a desired treatment region canexacerbate tissue trauma as well as unnecessarily prolong the medicalprocedure. Accordingly, there is a need for more precise endoscopemanipulation as well as manipulating an underlying treatment instrumentthrough an access channel of an endoscope.

Thus, it is desirable to have an endoscope assembly that can moreprecisely access the tortuous and relatively small cross-sectional areasof certain anatomical body lumens, and more precisely manipulate atreatment device provided within an access channel of an endoscope.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to an improvedendoscope system and a positioning device for manipulating a treatmentdevice that obviates one or more of the limitations and disadvantages ofprior medical devices.

In one embodiment, a medical device comprises an elongated flexible tubeincluding a distal end and a proximal end. The tube defines alongitudinal axis and a channel extending from the proximal end to anaperture at the distal end. A positioning mechanism is positionable atthe distal end of the flexible tube proximate the aperture andconfigured for rotation relative to the longitudinal axis of theflexible tube and lateral deflection at and relative to the distal endof the flexible tube to control a direction at which a treatmentinstrument extends from the aperture.

In various embodiments, the device may include one or more of thefollowing additional features: wherein a distal portion of thepositioning mechanism is housed within a recess at the distal end of theflexible tube, the positioning mechanism being configured for rotationabout a pin within the recess; wherein the positioning mechanismcomprises a tube housed within the channel; wherein a distal portion ofthe positioning mechanism is configured for lateral deflection throughactuation of a pull wire connected to the positioning mechanism andextending proximally within the elongated flexible tube; wherein adistal portion of the positioning mechanism is connected to the flexibletube by at least one spring, the distal portion of the positioningmechanism being configured for lateral deflection upon movement of awedge between the flexible tube and the distal portion of thepositioning mechanism; wherein a living hinge separates a distal portionof the positioning mechanism from a remaining portion of the positioningmechanism; wherein a pin extends through the distal portion of thepositioning mechanism and a distal portion of the tube housed within thechannel; wherein the aperture is a side facing aperture openinglaterally along the flexible tube; wherein the positioning mechanism isconfigured for movement through at least two degrees of freedom; whereinthe positioning mechanism is configured for movement through at leastthree degrees of freedom; wherein the positioning mechanism is rotatableabout two axes; wherein the positioning mechanism is configured forrotating a treatment instrument extended through the aperture relativeto the longitudinal axis of the flexible tube; wherein the medicaldevice is an endoscope that includes visualization components therein;wherein the medical device is an endoscope that includes illuminationcomponents therein; wherein the medical device is an endoscope thatincludes an additional positioning mechanism for controlled deflectionof the elongated flexible tube; wherein the positioning mechanismcomprises a sleeve configured to receive a treatment instrument therein,the sleeve being slidably housed and rotatable within the channel andhaving a distal end extendable beyond the aperture; further comprising adeflection control mechanism connected to a distal end of the sleeve andmoveable longitudinally and laterally within and relative to theflexible tube such that the distal end of the sleeve deflects relativeto the flexible tube; wherein the deflection control mechanism comprisesa pull wire connected to a distal end of the sleeve and housed within apull wire lumen within the flexible tube; wherein the pull wire lumenexhibits an arc shape configured to allow the pull wire to be rotatedfrom one end of the arc shaped lumen to another; wherein the sleeve isconfigured for movement through at least two degrees of freedom; whereinthe sleeve is rotatable about two orthogonal axes; wherein the sleeve isconfigured for movement through at least three degrees of freedom;wherein the sleeve is configured for selectively rotating a treatmentinstrument extended therein and beyond the aperture through apredetermined angle relative to the longitudinal axis of the flexibletube; further comprising a handle at the proximal end of the flexibletube, the handle including a control mechanism connected to a proximalend of the positioning mechanism configured for rotating the positioningmechanism within the channel of the flexible tube; wherein the controlmechanism comprises a cylindrical rotation post extending from arotation ring, the rotation ring being connected to a proximal end ofthe positioning mechanism; and wherein the control mechanism of thehandle includes a locking mechanism for fixing the orientation of thepositioning mechanism within the channel of the flexible tube.

Another embodiment is directed to a method of positioning a treatmentinstrument in a body comprising, providing a medical device comprised ofan elongated flexible tube including a distal end and a proximal end.The tube defines a longitudinal axis and a channel extending from theproximal end to an aperture at the distal end. A positioning mechanismis positionable at the distal end of the flexible tube proximate theaperture and configured for rotation relative to the longitudinal axisof the flexible tube and lateral deflection at and relative to thedistal end of the flexible tube to control a direction at which atreatment instrument extends from the aperture. The method includesinserting the medical device into an anatomical lumen of the body,inserting a treatment instrument through the channel, positioning thetreatment instrument by rotating the positioning mechanism relative tothe working channel of the flexible tube, and positioning the treatmentinstrument by laterally deflecting a distal portion of the positioningmechanism.

In various embodiments, the method may include one or more of thefollowing additional features: further comprising extending thetreatment instrument beyond the aperture of the flexible tube and intothe anatomical lumen; further comprising retracting the treatmentinstrument into the medical device, repositioning the medical devicewithin the anatomical lumen, applying torque to the positioningmechanism to rotate the treatment instrument housed therein, andextending the treatment instrument through the aperture; wherein thetreatment instrument is positioned within a bile duct during an ERCPprocedure; wherein the positioning mechanism is rotated 180 degreesrelative to the longitudinal axis of the flexible tube; wherein a distalportion of the positioning mechanism is housed within a recess at thedistal end of the flexible tube, and the distal portion of thepositioning mechanism is rotated about a pin within the recess; whereinthe positioning mechanism comprises a tube housed within the channel anda distal portion of the positioning mechanism is laterally deflectedthrough actuation of a pull wire connected to the positioning mechanismand extending proximally within the elongated flexible tube; wherein apin extends through the distal portion of the positioning mechanism anda distal portion of the tube housed within the channel; wherein thepositioning mechanism comprises a sleeve configured to receive atreatment instrument therein, the sleeve being slidably housed androtatable within the channel and having a distal end extendable beyondthe aperture; further comprising a deflection control mechanismconnected to a distal end of the sleeve and moveable longitudinally andlaterally within and relative to the flexible tube such that the distalend of the sleeve deflects relative to the flexible tube; and whereinthe deflection control mechanism comprises a pull wire and whereindeflection of the sleeve is controlled by proximal actuation of the pullwire.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art endoscope system.

FIG. 2 is a cross-sectional view illustrating the structure of a knownelevator device.

FIG. 3 illustrates an exemplary coordinate system for designatingtranslational and rotational displacement of elements in a system ofconnected bodies.

FIG. 4A is a cross-sectional view of a distal portion of an endoscopeaccording to an embodiment of the present invention.

FIG. 4B illustrates an alternative elevator arrangement at a distalportion of an endoscope according to an embodiment of the presentinvention.

FIG. 4C illustrates an alternative elevator arrangement at a distalportion of an endoscope according to an embodiment of the presentinvention.

FIG. 4D illustrates a proximal portion of an endoscope according to anembodiment of the present invention.

FIGS. 5A and 5B are front views of a distal part of an endoscopeaccording to an embodiment of the present invention.

FIG. 6 is a side view of a distal part of an endoscope according to anembodiment of the present invention.

FIG. 7 is a perspective view of a distal part of an endoscope accordingto an embodiment of the present invention.

FIGS. 8A and 8B are cross-sectional views of a distal portion of anendoscope according to another embodiment of the present invention.

FIG. 8C is a cross-sectional view of an endoscope taken along line C-Cin FIG. 8A.

FIGS. 9A and 9B are front views of a distal part of an endoscopeaccording to another embodiment of the present invention.

FIG. 10 illustrates the positioning of an endoscope and treatment devicewithin a patient's body portion.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts. The drawingfigures of this application are intended to provide a generalunderstanding of the working elements of the underlying system.Accordingly, unless explicitly stated, the figures do not represent aliteral depiction of proportional dimensions or the precise locationsfor the illustrated inter-related components.

According to exemplary embodiments, the invention relates to a medicaldevice for positioning a treatment device and/or viewing a patient'sinternal body portion. In embodiments that use a treatment device in anendoscopic medical procedure, the treatment device can be advancedthrough a working channel of an endoscope, including an endoscopespecifically designed and/or sized for use with the treatment device,and into a tissue tract. For purposes of this disclosure, “treatmentdevice” or “treatment instrument” includes, for example, any medicaldevice advanced through a working channel of an endoscope and for useduring an endoscopic procedure. Exemplary treatment instruments include,but are not limited to, guide wires, cutting or grasping forceps, biopsydevices, snare loops, injection needles, cutting blades, scissors,retractable baskets, retrieval devices, ablation and/orelectrophysiology catheters, stent placement devices, surgical staplingdevices, and balloon catheters.

FIG. 1 illustrates a known endoscope system. For purposes of thisdisclosure, “distal” refers to the end further from the device operatorduring use and “proximal” refers to the end closer to the deviceoperator during use. FIG. 1 depicts an endoscope 10 including a flexibleouter tube 12 extending between a distal end 14 and a proximal end 16 ofthe device. Endoscope 10 includes a treatment device insertion port 11for receiving a treatment device 20 into a working channel of theendoscope 10. The distal end 14 of the endoscope system 10 includes aside facing operation window 18 that can include visualization andlighting components for viewing during a treatment procedure. Inaddition, a working channel (not shown) extends within the endoscope 10and terminates at the operation window 18, thereby allowing thetreatment instrument 20 to be extended from the distal end of theendoscope 10. The extension of the treatment instrument 20 at a desiredtreatment site can be then viewed through the visualization components,which transmit images to the proximal end of the endoscope 10, as knownin the art. While FIG. 1 illustrates a side facing operation window 18,both front/forward facing and oblique/intermediate angled windows areknown.

FIG. 2 illustrates a cross-sectional view of a distal portion of a knownendoscope system including a deflecting lever/elevator device fordeflecting a treatment instrument as the instrument is extended beyond aworking channel of an endoscope. As seen in FIG. 2, a deflecting lever22 is rotated clockwise about a pin 24 by means of a pull wire 26connected to an upper portion of the deflecting lever 22. Upon actuationof the pull wire 26 through proximal movement thereof, the deflectinglever 22 deflects the treatment device 20 in order to alter the angle atwhich the treatment device 20 exits the endoscope's working channel,resulting in the position of device 20 shown by the dashed lines in FIG.2. Accordingly, arrow 21 depicts “lateral deflection” of device 20relative to the underlying endoscope body. By means of pull wire 26, theendoscope operator can control the placement of the treatment instrument20 as it is positioned during a medical procedure.

As seen in FIG. 1, a handle 28 at the proximal end 16 of the device caninclude various positioning controls 30 to effectuate bending androtation of the flexible outer tube 12 for positioning of the deviceduring a medical procedure. In addition, the handle can include adistinct positioning control for actuation of the deflection lever pullwire 26. During a medical procedure such as, for example, an ERCPprocedure, the treatment instrument 20 must be precisely inserted into aparticular duct in the biliary tree. While the use of a deflection lever26 is capable of altering the angle at which the treatment device exitsthe endoscope, precise positioning often requires repeated manipulationof the distal end of the endoscope including the operation window inorder to achieve proper placement of the treatment device 20. As notedabove, this repeated manipulation of the underlying endoscope 10 canlead to tissue trauma and unnecessarily prolong the entire medicalprocedure.

As seen in the embodiment of FIG. 2, the deflection lever 26 isdisplaceable about a single axis (i.e. the axis coincident with the pin24). Accordingly, lever 26 is movable about and only effectuatesmovement of the treatment device 20 through one degree of freedom.Precise manipulation of a treatment instrument is increased whenmanipulation is afforded along or about an additional particularcoordinate axis. A degree of freedom describes flexibility of motionadded due to displacement along or about a particular coordinate axis.

FIG. 3 illustrates a known Cartesian coordinate system illustrating thethree orthogonal axes of X, Y, and Z. A linkage or any system ofconnected bodies that has complete freedom of motion (even if only in alimited area) has six degrees of freedom. Three modes are translation(i.e. the ability to move in each of three dimensions in a directionparallel to each of the three orthogonal axes). An additional threemodes are rotation, i.e. the ability to change an angular positionaround the three orthogonal axes. Only three degrees of freedom arenecessary to move a structure anywhere in space, but additional degreesof freedom provide more versatility. For example, each of the followingis one degree of freedom: moving up and down along the Y axis (heaving);moving left and right along the X axis (swaying); moving forward andback along the Z axis (surging); tilting up and down (rotation Rx aboutthe X axis); turning left and right (rotation Ry about the Y axis); andtilting side to side (rotation Rz about the Z axis). Accordingly, apositioning mechanism that effectuates movement through more than onedegree of freedom will allow for more precise positioning of anunderlying treatment device.

FIG. 4A depicts a cross-sectional view of a distal end 14 of an improvedendoscope 10′. The distal portion of endoscope 10′ includes an exteriorflexible outer tube 12′, a side facing operation window aperture 32, anda working channel 34 forming a lumen within the endoscope 10′ andextending from the proximal end of the endoscope 10′ and terminating atthe operation window aperture 32. The flexible outer tube 12′ extendsalong a longitudinal axis 15. The working channel 34 extends proximallythrough the endoscope 10′ to a proximal working channel access portthrough which a treatment instrument can be tracked.

In addition, working channel 34 houses a separate torqueable flexibletube 36 configured for rotation within channel 34 and about thelongitudinal axis 15. Tube 36 can be formed, for example, from any knownmaterial suitable for use in medical procedures. For example, polymermaterials commonly used in medical device components are suitable forproviding a flexible, torqueable, component body. Alternatively, tube 36could be formed as a metal coil or braid or as a composite structure ofa polymer tube and metal coil or braid. Such an alternative structuremay exhibit enhanced properties for transmitting torque relative tostructure comprised of polymer alone.

Tube 36 is housed and extends proximally within the working channel 34.Tube 36 is configured to freely rotate within the working channel 34relative to the flexible outer tube 12′. In addition, the tube 36 issized to accommodate one or more treatment instruments therein foreffectuating positioning and placement of a treatment instrument duringa medical procedure. In order to facilitate the rotation of tube 36within the working channel 34, a portion of the outer surface of tube 36may be formed (or coated) with a thin layer of a lubricious polymermaterial, such as for example, polytetrafluoroethylene (PTFE). A layerof polymer material along the outer surface of tube 36 provides a lowfriction surface for contact with the corresponding internal surface ofworking channel 34. The lower friction surface reduces the potential forany resistance to free rotation of tube 36. Additionally, or as analternative, friction can also be lowered by use of known lubricantssuch as silicone oil, for example.

An additional thin layer of a lubricious polymer material may be coatedalong the inner surface of the working channel 34 to prevent galling ofthe contacting surfaces during movement of tube 36 relative to channel34 during use. The tube 36 extends distally within channel 34terminating at a distal opening 38 just proximal to the operation windowaperture 32. In addition, the tube 36 may be sized to accommodatevisualization components (not shown), such as, for example, fiber opticshoused within endoscope 10′ for viewing an internal treatment siteduring a medical procedure.

A deflection elevator 35 is housed within a recess 40 at the distal endof the endoscope 10′ at a position opposite the operation windowaperture 32. The elevator 35 is positioned for controlled lateraldeflection/rotation within the recess 40, for example, through rotationabout the axis of a pin 42 extending laterally through a pin aperture 43in elevator 35. The elevator 35 may include a curved concave surface 45(also see FIG. 7) configured to maintain contact with a treatmentinstrument 20 extended beyond the opening 38 of tube 36. The curvedsurface 45 of the elevator 35 acts as the surface for transferring adeflection force against a treatment instrument 20 during extension ofthe treatment instrument 20 through the endoscope 10′. As seen in FIG.4A, rotation of elevator 35 about pin 42 can be effectuated throughproximal actuation of a pull wire 44 connected to an upper portion ofthe elevator 35. Since the pin 42 is not connected to the flexible tube12′, the generation of a moment about the axis of pin 42 in order todeflect elevator 35 may require that the tube 36 be fixed in positionrelative to the flexible tube 12′. When tube 36 is fixed relative to theflexible tube 12′, the proximal actuation of pull wire 44 effectuatesrotational displacement of elevator 35 about the axis of pin 42 ratherthan the proximal displacement of tube 36 within working channel 34.

Accordingly, when tube 36 is fixed relative to outer tube 12′, proximalactuation of pull wire 44 generates a moment about the pin 42 therebyeffectuating controlled deflection of elevator 35. During use,controlled deflection of elevator 35 changes the angle at which atreatment instrument 20 exits endoscope 10′ through aperture 32, asshown in FIG. 6, for example. Additionally, or alternatively, the distalend of elevator 35 can be arranged to also deflect at an angle side toside relative to the longitudinal axis of tube 36 within the recess 40.In other words, the distal end of elevator 35 can be configured forrotation in a direction in and out of the page with regard to FIG. 4A(i.e. moving the distal end of elevator 35 in the direction of Ry aboutthe Y axis as depicted in FIG. 3). This rotation can be arranged, forexample, through a dual pull wire configuration controlling the side toside deflection of the distal end of elevator 35 relative to the distalend of the tube 36.

The elevator 35 is connected to a distal portion of lumen 36 such thatany rotation of lumen 36 relative to the longitudinal axis 15 alsoeffectuates rotation of elevator 35 about axis 15. Elevator 35 and lumen36 can be integrally formed as a single component. For example, theelevator 35 and lumen 36 can be formed through a molding processresulting in a single component. Alternatively, elevator 35 and lumen 36can be connected through any known method for connecting workingelements of an endoscopic system. One connection, for example,illustrated in FIG. 4A, depicts pin 42 extending through both elevator35 and a distal portion of lumen 36. Accordingly, in the illustratedembodiment, pin 42 serves as the axis about which elevator 35 rotates totransmit deflection to a treatment instrument 20 and also serves as theelement through which elevator 35 and lumen 36 are connected. In orderto assure a reliable connection, a portion of lumen 36 at the distal endof lumen 36 can be provided with a solid mounting block portion throughwhich pin 42 can extend. Such a solid mounting block for receiving pin42 increases the amount of surface area through which torque istransferred from the proximal end of lumen 36 to elevator 35.

As another example, the connection of elevator 35 and lumen 36 could becompleted through an arrangement as depicted in FIG. 4B. FIG. 4Billustrates a disassembled arrangement of an elevator 35′ and lumen 36′.The arrangement of FIG. 4B is similar to elevator 35 and lumen 36 exceptthat the previously described mounting block arrangement has beenreplaced with dual side arm posts 33 each having a pin aperture 43′through which pin 42 extends after assembly. In addition, the distal endof lumen 36′ could be capped with a thin walled metal tube. This metaltube would have the strength to support its own aperture 43′ forreceiving pin 42. Just as in FIG. 4A, in FIG. 4B, pin 42 extends throughthe elevator 35′ and lumen 36′ thereby connecting the two and allowinglateral deflection of the elevator 35′ relative to the lumen 36′.

As another example, instead of using a pull wire 44, deflection controlof an elevator can be provided through an arrangement combining at leastone spring and a wedge element. FIG. 4C depicts an arrangement of anelevator 35″ and a wedge 49. For example, elevator 35″ can be connectedwithin a recess 40 (see, e.g., FIG. 4A) at a distal end of an endoscopeby a distal spring 51A and a proximal spring 51B. A wedge 49 having aramp 53 can be provided and configured for longitudinal movement in thedirection of arrow 55 underneath an elevator 35″. Upon forward movementof the wedge 49 underneath the elevator 35″, contact between the surfaceof ramp 53 and the underside of elevator 35″ results in a lateraldeflection of the elevator 35″ about pin 42. Springs 51A and 51B of apredetermined force constant are positioned such that the controlledlongitudinal displacement of wedge 49 provides an alternative system forproviding lateral deflection.

As yet another example, the device of FIG. 4A could work without a pin42. The elevator 35 could be rigidly attached to the lumen 36. A livinghinge feature could be incorporated into the structure of the elevator35 in the location where the pin is depicted in FIG. 4A. Living hingesare thin sections of material that connect two segments of a part tokeep them together and allow one part to be repeatedly moved relative toanother, such as, for example, the hinge arrangement in a plastictoolbox. This living hinge would be a discrete thin section in theelevator structure designed so that the elevator would bend at thatlocation.

As noted above, elevator 35 is configured for clockwise rotation aboutpin 42 through actuation of pull wire 44. Pull wire 44 is connected atan upward offset distal position along the elevator 35 such thatproximal movement of pull wire 44 rotates the elevator 35 about rotationpin 42. The pull wire 44 extends proximally within a pull wire channel(not shown) of the endoscope 10′ where it extends for connection with apositioning control device at a handle at the endoscope's proximal end.As pull wire 44 is displaced in a proximal direction, the elevator 35,and in turn a treatment instrument 20, are rotated such that the angleat which treatment instrument 20 extends from the endoscope 10′ isincreased.

Pull wire 44, for example, can extend for connection to a bending leveror rotation wheel control device where proximal actuation can beeffected by an operator. While a pull wire element is illustrated as themechanism for deflection of the elevator 35, alternative deflectionmechanisms can be used, including, but not limited to, forward actingpush wires, or stylets, electronic piezoelectric bending transducers,electroactive polymers, shape memory materials, and an inflatable cuffelement underlying the elevator 35.

FIG. 4D, for example, depicts one embodiment for a handle 37 provided atthe proximal end of the endoscope 10′. As seen in FIG. 4D, the flexibleouter tube 12′ extends proximally to a handle 37. Handle 37 may includea cylindrical rotation post 39 extending from a rotation ring 41. Thering 41 is rotatably connected to a proximal end of tube 36 such thatrotation of post 39 and ring 41 effectuates rotation of tube 36 withinthe working channel 34 of the endoscope 10′. In addition, the rotationring 41 can incorporate a locking mechanism for releasably fixing therotational and longitudinal position of tube 36 relative to the workingchannel 34. Exemplary locking mechanisms include, but are not limitedto, a constricting rubber grommet mechanism, a ratchet, a thumbscrew, abutton, and an extendable pin and receiving aperture arrangementconfigured for mating engagement along a proximal end of the tube 36.Alternatively, the operator can simply maintain the position of tube 36relative to the working channel 34 by hand.

Handle 37 also comprises a deflection control slide ring 47 connected toa proximal portion of the pull wire 44. As seen in FIG. 4D, the slidering 47 extends back and forth along a slide channel formed along theexterior of the handle 37. Distal and proximal movement of slide ring 47relative to the exterior surface of the handle 37, effectuates distaland proximal movement of the pull wire 44, which actuates deflection ofelevator 35, as seen in FIG. 4A. Accordingly, upon proper orientation oftube 36, an operator can fix the position of tube 36 relative to theworking channel 34 and commence deflection of elevator 35 as desired.

While a slide ring and rotation post arrangement is illustrated,alternative handle positioning configurations are also contemplated. Forexample, the pull wire 44 can be extended and retracted by a worm geararrangement, a rack and pinion arrangement, a lever, a typical rotationknob on an endoscope, through electronic means, or any alternativemechanism for effectuating longitudinal displacement of an elongatedcomponent.

Because tube 36 is configured for rotation about the longitudinal axis15 of the endoscope 10′, and elevator 35 is configured for controlledrotation about the axis of pin 42, endoscope 10′ is capable ofdisplacing a treatment instrument 20 through at least two degrees offreedom. FIGS. 5A and 5B, for example, illustrate a degree of freedompermitting rotation of a treatment instrument 20 within the workingchannel 34 of the underlying endoscope 10′. Referring to FIGS. 5A and5B, an exemplary range of rotation for tube 36, elevator 35, and atreatment instrument 20 associated therewith is illustrated. FIG. 5A isa front view of endoscope 10′ depicting the counter-clockwise (viewingfrom the distal end) rotation of tube 36 within the endoscope 10′.Rotation of tube 36 is transferred into rotation of elevator 35, and inturn effectuates rotation of treatment instrument 20. FIG. 5Aillustrates rotation of elevator 35 through an angle α of about 55degrees relative to a vertical plane P bisecting the endoscope 10′ inFIG. 5A. Conversely, FIG. 5B illustrates a front view of endoscope 10′depicting the clockwise (viewing from the distal end) rotation of tube36 within the endoscope 10′. In FIG. 5B, rotation of elevator 35 in adirection opposite that of FIG. 5A is depicted through an angle α′ ofabout 55 degrees relative to a vertical plane bisecting the endoscope10′. While a combined angular rotation of 110 degrees is illustrated,alternative rotational ranges are possible and the example of 110degrees is not intended to be limiting. The overall range of rotationfor tube 36 and elevator 35 may be limited by the configuration of theboundary of aperture 32, which houses the elevator 35. For example, asseen in FIGS. 5A and 5B, treatment instrument 20 can be rotated relativeto the outer flexible tube 12′ of the endoscope 10′ only until anexterior side surface of treatment instrument 20 comes in contact withthe boundary of aperture 32.

FIG. 6 depicts a side view of the distal portion of endoscope 10′ and,in particular, the deflection of a treatment instrument 20 through anadditional degree of freedom from that illustrated in FIGS. 5A-5B.Actuation of deflection pull wire 44, illustrated in part in dashedlines in FIG. 6, causes rotation of elevator 35 in order to increase ordecrease the deflection angle β at which the treatment instrument 20extends from the working channel of underlying endoscope 10′. As notedabove, the generation of a moment about the axis of pin 42 in order todeflect elevator 35 may require that the tube 36 be fixed in positionrelative to the flexible tube 12′. When tube 36 is fixed relative to theflexible tube 12′, the proximal actuation of pull wire 44 effectuatesrotation of elevator 35 about pin 42 and causes lateral deflection oftreatment instrument 20 between an angle of about 30 degrees to about135 degrees relative to the longitudinal axis 15 of the endoscope 10′.

FIG. 7 is a perspective view of a distal part of an endoscope 10′. FIG.7 depicts a distal portion of an endoscope 10′ including an aperture 32leading to a recess that houses elevator 35. Elevator 35 can bemanipulated through two distinct degrees of freedom in order to moreprecisely position a treatment instrument within an endoscope. As notedabove, one degree of freedom is permitted through rotation of elevator35 about the axis of pin 42, while another separate degree of freedom ispermitted through rotation of lumen 36 relative to longitudinal axis 15.

FIGS. 8A-9B illustrate another embodiment for effectuating more precisemanipulation of a treatment instrument within a working lumen of anendoscope. FIG. 8A depicts an arrangement of a distal portion of anendoscope 10″ including a positioning mechanism for manipulation of atreatment instrument 20. In FIG. 8A, a treatment instrument 20 isinserted within an extendable sleeve 60 housed within the workingchannel 34 that extends through endoscope 10″. Slidable sleeve 60extends within the channel 34 and is configured for movement relative tothe channel 34. Sleeve 60 can be extended back and forth through workingchannel 34 where, in side facing operation window embodiments, a ramp 52leads to the exterior of the endoscope 10″ through a side port aperture54.

A sleeve deflection pull wire 62 connects to a distal end of the sleeve60 and extends proximally through a pull wire lumen 64 within theflexible tube 12′. The sleeve 60 may be configured to exhibit apredetermined level of rigidity such that a treatment instrument 20extended therethrough will be reliably directed coincident with thedirection sleeve 60 extends from the working channel 34. For example,during a treatment procedure, sleeve 60 can be used to position thepoint in space at which the distal end of a treatment instrument 20 islocated within a patient's body. This further positioning adjustmentmechanism is advantageous in that the distal end of a treatmentinstrument 20 can be precisely located without requiring repeatedmanipulation and trauma-causing movement of the entire underlyingendoscope body. If the extended sleeve 60 is easily deflected andcollapsible during contact with internal body tissues, proper controland repeatable placement of sleeve 60 (and in turn the treatmentinstrument 20 extended therethrough) may not be possible.

FIG. 8B depicts sleeve 60 extended outside the working channel 34 ofendoscope 10″. FIG. 8B also depicts controlled deflection of sleeve 60through proximal actuation of pull wire 62 in the direction of arrow 67.Proximal displacement of pull wire 62 draws the distal end of sleeve 60closer to the distal opening of pull wire lumen 64. Therefore, precisecontrol of the angle at which sleeve 60 extends outside the workingchannel 34 is effectuated through manipulation of pull wire 62. Duringuse, an operator may control the placement of a treatment instrument 20by extending the sleeve 60 to a desired position and then selectivelyactuating pull wire 62 while fixing the longitudinal position of theproximal portion of sleeve 60 within the working channel 34. Therefore,the distal orientation of the sleeve 60 can be selectively manipulatedwithout effecting displacement of any portion of sleeve housed withinchannel 34.

FIG. 8C depicts a cross-sectional view through endoscope 10″ taken alongline C-C in FIG. 8A. As seen in FIG. 8C, pull wire lumen 64 may beformed in an arc shape which allows for angular displacement of the pullwire 62 through a predetermined angle corresponding to the size of thearc-shaped lumen 64. For example, during a medical procedure, sleeve 60may be rotated within the channel 34. After rotation of a sleeve 60relative to channel 34, actuation of pull wire 62 will effectuatebending of sleeve 60 at only one angular orientation unless pull wire 62is also free to move laterally relative to the exterior surface ofendoscope 10″. In the illustrated embodiment this lateral movement isaccomplished by lateral movement of the pull wire 62 within the lumen64, for example, by movement of the pull wire from one end lateral endof the lumen 64 to another. While the lumen 64 is illustrated as havingan arc shape, alternative shapes are possible, so long as lateralmovement of pull wire 62 is permitted.

Through the arrangement depicted in FIG. 8C, lumen 64 is shaped to housepull wire 62 throughout a predetermined angular displacement, such as,for example, a range of 180 degrees. In addition, in is contemplatedthat angular displacement may include a range of up to 360 degrees.Accordingly, upon combined rotation of sleeve 60, lateral movement ofpull wire 62, and proximal deflection of pull wire within lumen 64,sleeve 60 can be deflected through a range of angular orientationrelative to the longitudinal axis 15 of endoscope 10″.

FIGS. 9A and 9B depict the controlled displacement of sleeve 60 throughthree degrees of freedom, i.e. one controlling a degree of lateraldeflection as sleeve 60 extends from the endoscope 10″, anothercontrolling the angular orientation, or rotation of sleeve 60 relativeto the longitudinal axis of endoscope 10″, and another controlling thedistance sleeve 60 extends beyond the working channel 34.

FIG. 9A for example, illustrates a front view of endoscope 10″ depictingthe counter-clockwise (viewing from the distal end) rotation of sleeve60 and pull wire 62 within the endoscope 10″. Rotation of sleeve 60 andpull wire 62 is depicted through an angle α″ of about 55 degreesrelative to a vertical plane P bisecting the endoscope 10″. Conversely,FIG. 9B illustrates a front view of endoscope 10′ depicting theclockwise (viewing from the distal end) rotation of sleeve 60 and pullwire 62 within the endoscope 10″. In FIG. 9B, the sleeve 60 and pullwire 62 are rotated in a direction opposite that of FIG. 9A and depictedas rotated through an angle α′″ of about 55 degrees relative to verticalplane P bisecting the endoscope 10″. While a combined angular rotationof about 110 degrees is illustrated, alternative ranges of rotation arepossible and the example of 110 degrees is not intended to be limiting.

It is contemplated that all of the embodiments disclosed herein mayinclude manipulating pull wires similar to pull wire 62 illustrated inFIGS. 8A-9B. For example, each of the treatment device 20, tube 36, andsleeve 60 can be arranged to include up to four pull wires to add two ormore additional degrees of freedom to the tip of the endoscopicpositioning system described herein. In addition, it is contemplatedthat any of treatment device 20, tube 36, sleeve 60, and elevators 35and 35′ may be incorporated with a return spring element for resilientlybiasing the associated element toward a “home” position.

FIG. 10 illustrates the positioning of an endoscope 10′ or 10″ and atreatment device 20 within a patient's body portion. In particular, FIG.10 depicts the extension of a treatment instrument 20 within aparticular bile duct 80 during an ERCP procedure. As seen in FIG. 10,the endoscope 10′, for example, is inserted and extended through apatient's stomach 82 such that the distal end and aperture 32 (notshown) of endoscope 10′ are positioned in close relation to a particularbile duct 80 leading to, for example, gall bladder 84. As seen in FIG.10, treatment instrument 20 is extended beyond the internal workingchannel 34 of endoscope 10′. The treatment instrument 20 can then beprecisely manipulated, for example, by controlled rotation of tube 36and deflection of elevator 35, described in FIGS. 4A-7. Alternatively,the instrument 20 can be manipulated using the embodiment of endoscope10″ described in FIGS. 8A-9B. In the embodiment of endoscope 10″,manipulation of treatment instrument 20 is effectuated throughmanipulation of sleeve 60 and pull wire 62.

Precise manipulation of treatment instrument 20 allows for more precisepositioning and location of instrument 20 such as, for example, duringplacement of instrument 20 within a particular bile duct 80 of interest.More precise manipulation of a treatment device 20 can result inshortened treatment procedures by reducing the amount of time necessaryto effectuate proper position of the treatment device 20. In addition,controlled deflection of the angle at which treatment device 20 exitsthe underlying endoscope 10′, 10″ can reduce internal tissue traumacaused during endoscopic procedures requiring repeated repositioning andmanipulation of the entire endoscope. For example, the positioningmechanisms described in FIGS. 4A-9B facilitate the location of treatmentinstrument 20 within a particular bile duct 80 without repeatedmanipulation and displacement of the underlying endoscope body.Accordingly, the occurrence of tissue trauma during a treatmentprocedure can be reduced.

While the above described positioning system has been depicted asutilizing pull wire manipulation mechanisms for effectuating deflectionof elevator 35 and sleeve 60, the invention it not intended to belimited to this particular structure. Therefore, alternative actuationdevices are intended to be within the scope of this invention, includingall equivalent structures known for transferring endoscopic manipulationforces along the longitudinal axis of an endoscope. In addition to thepositioning mechanisms disclosed above, the system of this applicationmay further include other additional positioning mechanisms, such asthose for achieving controlled deflection of the elongated flexible tubeof the endoscope.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A medical device, wherein the medical device is an endoscope thatincludes visualization components, the medical device comprising: anelongated flexible tube including a distal end and a proximal end, thetube defining a longitudinal axis and a channel extending from theproximal end to an aperture at the distal end; and a positioningmechanism positionable at the distal end of the flexible tube proximatethe aperture, the positioning mechanism configured for rotation relativeto the distal end of the flexible tube and around the longitudinal axisof the flexible tube and lateral upward deflection at and relative tothe distal end of the flexible tube to control a direction at which atreatment instrument extending through the tube extends from theaperture, wherein the rotation of the positioning mechanism isindependent of the upward deflection of the positioning mechanism. 2.The medical device of claim 1, wherein a distal portion of thepositioning mechanism is housed within a recess at the distal end of theflexible tube, wherein the upward deflection of the positioningmechanism includes rotation of the positioning mechanism about a pinwithin the recess.
 3. The medical device of claim 1, wherein thepositioning mechanism comprises a tube housed within the channel.
 4. Themedical device of claim 3, wherein a distal portion of the positioningmechanism is configured for upward deflection through actuation of apull wire connected to the positioning mechanism and extendingproximally within the elongated flexible tube.
 5. The medical device ofclaim 3, wherein a living hinge connects a distal portion of thepositioning mechanism to a remaining portion of the positioningmechanism.
 6. The medical device of claim 4, wherein a pin extendsthrough the distal portion of the positioning mechanism and a distalportion of the tube housed within the channel.
 7. The medical device ofclaim 1, wherein the aperture is a side facing aperture openinglaterally along the flexible tube.
 8. The medical device of claim 1,wherein the positioning mechanism is configured for movement through atleast two degrees of freedom.
 9. The medical device of claim 1, whereinthe positioning mechanism is configured for movement through at leastthree degrees of freedom.
 10. The medical device of claim 8, wherein thepositioning mechanism is rotatable about two axes.
 11. The medicaldevice of claim 1, wherein the positioning mechanism is configured forrotating a treatment instrument extended through the aperture relativeto the longitudinal axis of the flexible tube.
 12. The medical device ofclaim 1, wherein the medical device is an endoscope that includesillumination components therein.
 13. The medical device of claim 1,wherein the medical device is an endoscope that includes an additionalpositioning mechanism for controlled deflection of the elongatedflexible tube.
 14. The medical device of claim 1, wherein thepositioning mechanism comprises a sleeve configured to receive atreatment instrument therein, the sleeve being slidably housed androtatable within the channel and having a distal end extendable beyondthe aperture; and a deflection control mechanism connected to a distalend of the sleeve and moveable longitudinally and laterally within andrelative to the flexible tube such that the distal end of the sleevedeflects relative to the flexible tube.
 15. The medical device of claim14, wherein the deflection control mechanism comprises a pull wireconnected to a distal end of the sleeve and housed within a pull wirelumen within the flexible tube.
 16. The medical device of claim 15,wherein the pull wire lumen exhibits an arc shape configured to allowthe pull wire to be moved from one end of the arc-shaped lumen toanother end of the arc-shaped lumen.
 17. The medical device of claim 14,wherein the sleeve is configured for movement through at least twodegrees of freedom.
 18. The medical device of claim 17, wherein thesleeve is rotatable about two orthogonal axes.
 19. The medical device ofclaim 14, wherein the sleeve is configured for movement through at leastthree degrees of freedom.
 20. The medical device of claim 14, whereinthe sleeve is configured for rotating a treatment instrument extendedtherein and beyond the aperture through an angle relative to thelongitudinal axis of the flexible tube.
 21. The medical device of claim1, further comprising a handle at the proximal end of the flexible tube,the handle including a control mechanism connected to a proximal end ofthe positioning mechanism configured for rotating the positioningmechanism within the channel of the flexible tube.
 22. The medicaldevice of claim 21, wherein the control mechanism comprises a postextending from the handle and connected to a proximal end of thepositioning mechanism.
 23. The medical device of claim 21, wherein thecontrol mechanism of the handle includes a locking mechanism for fixingthe orientation of the positioning mechanism within the channel of theflexible tube.
 24. The medical device of claim 3, wherein a distalportion of the positioning mechanism comprises a deflection elevatorincluding a curved, concave surface.
 25. The medical device of claim 24,wherein the curved, concave surface is configured to transfer adeflection force against a treatment instrument extending through theelongated flexible tube.
 26. The medical device of claim 25, wherein thedeflection elevator and the tube are integrally formed as a singlecomponent.
 27. The medical device of claim 4, further comprising a slidemechanism connected to a proximal portion of the pull wire, and whereinproximal and distal movement of the slide mechanism causes the upwarddeflection of the positioning mechanism.
 28. The medical device of claim1, wherein the positioning mechanism is configured for rotation in aclockwise direction and a counterclockwise direction relative to thedistal end of the flexible tube and around the longitudinal axis of theflexible tube.
 29. The medical device of claim 3, wherein a distalportion of the positioning mechanism is connected to the tube, andwherein rotation of the tube causes the rotation of the positioningmechanism around the longitudinal axis of the flexible tube.
 30. Amedical device, wherein the medical device is an endoscope that includesvisualization components, the medical device comprising: an elongatedflexible tube including a distal end and a proximal end, the tubedefining a longitudinal axis and a channel extending from the proximalend to an aperture at the distal end; and a positioning mechanismpositionable at the distal end of the flexible tube proximate theaperture, the positioning mechanism configured for rotation relative tothe distal end of the flexible tube and around the longitudinal axis ofthe flexible tube and upward deflection at and relative to the distalend of the flexible tube to control a direction at which a treatmentinstrument extending through the tube extends from the aperture,wherein, when the positioning mechanism is not deflected upwardsrelative to the distal end of the flexible tube, the positioningmechanism is rotatable in a clockwise direction and a counterclockwisedirection relative to the distal end of the flexible tube and around thelongitudinal axis of the flexible tube.
 31. The medical device of claim30, wherein a distal portion of the positioning mechanism is configuredfor upward deflection through actuation of a pull wire connected to thepositioning mechanism and extending proximally within the elongatedflexible tube.
 32. The medical device of claim 30, further comprising ahandle at the proximal end of the flexible tube, the handle including acontrol mechanism connected to a proximal end of the positioningmechanism configured for rotating the positioning mechanism within thechannel of the flexible tube.
 33. The medical device of claim 30,wherein the positioning mechanism comprises a tube housed within thechannel.
 34. The medical device of claim 33, wherein a distal portion ofthe positioning mechanism is connected to the tube, and wherein rotationof the tube causes the rotation of the positioning mechanism around thelongitudinal axis of the flexible tube.